From: Doris Lantz [dhlantz@nls.net]
Sent: Friday, December 29, 2000 6:22 PM
To: Morrison, James C
Subject: Recent phenylpropanolamine ruling --> Adverse health situation
caused by the ruling

Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
 
Dear Mr Morrison:
 
The FDA brief, "Food and Drug Administration Science Background: Safety
of Phenylpropanolamine," November 6, 2000, indicates that even though
the "... risk of hemorrhagic stroke is very low...FDA plans to act to
remove phenylpropanolamine as an ingredient in OTC and prescription drug
products." The reason given for this action with regard to nasal
decongestants is that "Alternate nasal decongestants which do not
contain phenylpropanolamine are available both OTC and by prescription."
Did the FDA ever consider that for a substantial population the
available alternative decongestant ingredients might be medically
unacceptable?
 
I have regularly used Entex LA (PPA and guaifenesin) or its equivalent
over a decade for my chronic sinus condition. Without the Entex, sinus
infections were mostly the norm. (I required sinus surgery twice.) This
is the drug of choice for me, because it does the job with minimal CNS
effects. However, following your announcement, Merck-Medco declined to
refill the rest of my Entex prescription. A half-hour phone call with
Merck-Medco and a drug search by them revealed that only two alternative
decongestant ingredients are available: pseudoephedrine and
phenylephrine.  I cannot tolerate pseudoephedrine for more than a day or
two because of clearly correlated and unacceptable nervous
stimulation-being "wired" during the day and having serious sleep
disturbances at night. Therefore, my doctor prescribed a phenylephrine
product, Liquibid-D (long acting and combined with guaifenesin, just
like Entex LA).  Unfortunately, the second and third times I took the
phenylephrine product-at half the recommended dosage- unambiguously
produced worse nervous effects than I recall having with pseudoephedrine
(Note 1). My regular use of this medication is emphatically
unacceptable. Therefore, I am now left with no medication alternatives
and the prospect of chronic sinus infections. I would gladly exchange
the *chance* of a hemorrhagic stroke for the virtual *certainty* of
feeling rotten most of the time. However, the FDA ruling denies me, and
my doctor, that choice.
 
I cannot expect the FDA to base rulings on the needs of one individual.
Not everyone experiences such side effects. However, given the size of
the US population, the prevalence of chronic sinus conditions, and the
documented CNS side effects of pseudoephedrine and phenylephrine, I
strongly suspect that at least hundreds of thousands of Americans are
now left without an acceptable remedy. Therefore, I ask you to kindly
consider modifying the final ruling to allow manufacture and
prescription use of phenylpropanolamine for such situations. 
 
----    Joel Lantz, 6693 Tamarind Drive, Bedford Heights, Ohio 44146
 
CC:  Representative Stephanie Tubbs Jones
        Senators Mike DeWine and George Voinovich
        Phillip Cusumano, MD
 
_______________________
(1) And, being that phenylephrine is also used clinically to raise blood
pressure, I cannot help but wonder whether it poses at least as high a
risk for hemorrhagic stroke as phenylpropanolamine.